PRINCETON, N.J. — SunGen Pharma announced it has received its eighth ANDA approval from the US Food and Drug Administration (FDA).

The eighth approved ANDA is for Lidocaine Ointment USP, 5%, Package size: 1 ½ oz tube (35.44 g). This drug product is used for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. This drug has annual sales of about 60 million US dollars.

“These approvals represent one of many products being developed or co-developed by our company and with our partners globally. Today, we have more than forty active products in our pipeline and over twenty co-development, licensing, CMO and sales and marketing partnerships around the world,” said Dr. Isaac Liu, co-founder and co-chuef executive officer of the company.  “Our high-quality development expertise and capability is now expanded to topical dosage forms and is further demonstrated by the short approval timeline. We will continue to focus on development of highly selective products that are niche and high barrier to entry with high value added to U.S. and Asian markets,” said Dr. Jim Huang, co-founder and co-chief executive officer of the company.